Minneapolis, MN – COMPLIANCE / REGULATORY SPECIALIST – Medical Device

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Vallon LifeScience – Our client, a medical device company, is looking for an experienced COMPLIANCE / REGULATORY SPECIALIST
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Position is part of the Regulatory Affairs team and will be responsible for the following:

• Interpreting company policies and industry regulations to answer federal healthcare compliance and device industry regulatory questions from employees
• Developing compliance related programs and participating in compliance training
• Overseeing credentialing management program; providing general regulatory support to the department and company
• Participating on the compliance audit team
• Preparing annual compliance filings
• Evaluating and responding to sponsorship request
• Conducting contract reviews relative to compliance
• Updating and maintaining Device Master Records (DMR’s)
• Managing risk management data including updating hazard analysis database
• Responding to customer requests
• Supporting the universal bar code regulation implementation 

In this challenging career position, the required qualifications are:

• Bachelor’s degree from a four-year college or university with a focus on technical, business or medical related field is preferred.
• Must have two – four years of related work experience in a FDA regulated industry (such as medical device or pharmaceutical). 
• Must have general knowledge of device industry regulations including FDA and federal healthcare regulations and quality management systems.
• Prior auditing experience is preferred.
• Excellent communication and organization skills.
• Desire and ability to thrive in a highly participative team environment.

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Local candidates only.

Send resume to katerichards@vallonllc.com
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Include CRS  in subject line.

 

Minneapolis, MN – Contract HR with European Hiring Expertise

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Vallon LifeScience – Our client is looking for a CONTRACT HUMAN RESOURCE professional with EUROPEAN HIRING expertise
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Our client is expanding their operations into Europe and require an HR contractor to help with the hiring of employees in a number of European countries.  Contractor needs to ensure local laws are adhered to and consider impact of termination rules within each country.  This engagement requires approximately 4-10 hours of assistance monthly as our clients ramps up their business.

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Local candidates only.

Send resume to katerichards@vallonllc.com
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Include HR in subject line.

Senior Software Engineer

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Assignment Title	Senior Software Engineer
Location	Minneapolis, MN
Term	Approximately 2-3 months
Other Background	Design, develop and support responsibility for existing and future embedded and PC software systems for medical devices, as well as supervisor responsibility for the programming staff.

Requirements

Prepare appropriate software requirements and design specifications to serve as guidance for development, manufacturing and testing of medical devices.

Programming in C and Atmel ARM-based solutions.

Prepare verification protocols to test and establish that design requirements have been met.

Prepare flow charts, state diagrams, state tables and other software design documents.

Conduct design review meetings and document minutes and related documents to summarize and communicate progress.

Write and debug software for embedded and PC applications and test programs using selected software languages and operating systems.

Perform appropriate software engineering studies to identify and fulfill software needs of devices and systems.

Gain increased understanding of customer needs through direct interface at sites, shows and conferences. Information obtained will serve to create or refine existing User Requirements and Design Specifications.

Aid in development of software design processes and procedures for embedded and PC systems used in the development, manufacturing and support of medical devices.

Prepare Standard Operating Procedures (SOPs) to meet Quality and Regulatory requirements.

A BS degree in Electronic, Computer or Software Engineering is required. Additional training in electronics and software, beyond formal degree, is strongly desirable.

Present progress reports to small groups.

Highly organized to address both program and cGMP (current Good Manufacturing Practices) needs.

Interface with management, peers and subordinates along with Quality Systems, Regulatory, Production, Customers and vendors.  Interface with Electrical and Mechanical Engineers, Microbiologists, Physicists and support staff in an integrated development environment.

 

 

Minneapolis, MN – Contract Software Development Engineer

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Vallon LifeScience – Our client is looking for a CONTRACT SOFTWARE DEVELOPMENT ENGINEER. ************************************************************************ Architect & develop programming software for our client's product.

KEY DUTIES & RESPONSIBILITIES

Define requirements, specifications & architects software UI systems that communicate with implanted products.
Implement algorithms for new product features to support research.
Design, define, implement software input/output processes & working parameters by using current systems engineering methods & technologies.
Document system requirements by writing documents, reports, memos & change requests.
Methods used are determined by approved procedures & standards. Analyze, design, program, debug and modify software aps.

TECHNOLOGY REQUIREMENTS
BSCSCI, Software Engineering & 3 plus years of relevant experience Microsoft UI Platforms
.Net framework development experience with Winforms & WPF OOAD
Extensive knowledge of C# required.
Visual Basic .Net experience helpful.
Ability to work in a fast-paced environment & meet objectives

PREFERRED: MSCSCI preferred. ************************************************************************ Local candidates only. Send resume to katerichards@vallonllc.com ************************************************************************ Include CSE in subject line.

Quality Engineer

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Job Title	Quality Engineer within the Design Control/Product Development area
Location	West metro
Term	20 hours/week for 4 weeks beginning in September.
Other Background	The company is relocating their product development lab test equipment.  There is a master validation plan already underway with a contractor who has worked with this client for many years.

Requirements

Medical Device

Quality Engineer

Leadership

Design control/product development

Experience with relocation of product development lab test equipment or operations/manufacturing equipment.

Write protocols & reports for IQ (installation qualification) and OQ (operation qualification).  Document the important features to consider in moving specific equipment.

Hands on equipment testing is not required.

Partner with the Director of Facilities to create the equipment relocation protocol and test plan.

Requires approximately 20 hours/week for 4 weeks beginning in early September.